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Cardiovascular Risk Factors And Intensive Dietary Counselling

Primary Purpose

High Blood Pressure, Hypercholesterolemia, Tobacco Smoking

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group-level Intensive dietary Counselling
Individual-level Intensive Dietary Counselling
Sponsored by
Andalusian Regional Ministry of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Blood Pressure focused on measuring Cardiovascular risk, Primary prevention, Intensive dietary counselling, Physical exercise

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 40-65 years
  • Presence of any cardiovascular risk factors (Hypertension, Hypercholesterolemia, tobacco smoking, diabetes, obesity)

Exclusion Criteria:

  • Currently diagnosed with any vardiovascular disease
  • Currently involved in any other clinical trial
  • Cognitive impairment that prevents from providing an informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group-level Intensive Dietary Counselling

    Individual-level Intensive Dietary Counselling

    Arm Description

    Active learning through 4-6 60-minute sessions workshop, enrolling 8-12 people each time.

    Individualised dietary counselling delivered at the health-care point

    Outcomes

    Primary Outcome Measures

    Cardiovascular risk as calculated by means of the SCORE (Systematic Coronary Risk Evaluation) scale. Low-risk regions version.

    Secondary Outcome Measures

    Health-Related Quality of Life
    Spanish version of the EQ-5D-5L questionnaire by the EuroQol Group

    Full Information

    First Posted
    June 24, 2014
    Last Updated
    June 24, 2014
    Sponsor
    Andalusian Regional Ministry of Health
    Collaborators
    Andaluz Health Service
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02173600
    Brief Title
    Cardiovascular Risk Factors And Intensive Dietary Counselling
    Official Title
    Estimation of Cardiovascular Risk After Intensive Dietary Counselling in a Primary Care Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Andalusian Regional Ministry of Health
    Collaborators
    Andaluz Health Service

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The Intensive Dietary Counselling (IDC) intervention is a prevention and health promotion activity. It is being implemented by the Andalusian Health Service to reinforce basic intervention advice on healthy diet and exercise. The IDC intervention is aimed at the prevention of diseases of the heart and blood vessels (e.g. heart failure, heart attack and stroke). The main objective of the present study is to assess adherence to the IDC intervention and, consequently, its effectiveness on the prevention of the above mentioned diseases.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Blood Pressure, Hypercholesterolemia, Tobacco Smoking
    Keywords
    Cardiovascular risk, Primary prevention, Intensive dietary counselling, Physical exercise

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    630 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group-level Intensive Dietary Counselling
    Arm Type
    Experimental
    Arm Description
    Active learning through 4-6 60-minute sessions workshop, enrolling 8-12 people each time.
    Arm Title
    Individual-level Intensive Dietary Counselling
    Arm Type
    Active Comparator
    Arm Description
    Individualised dietary counselling delivered at the health-care point
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group-level Intensive dietary Counselling
    Intervention Type
    Behavioral
    Intervention Name(s)
    Individual-level Intensive Dietary Counselling
    Primary Outcome Measure Information:
    Title
    Cardiovascular risk as calculated by means of the SCORE (Systematic Coronary Risk Evaluation) scale. Low-risk regions version.
    Time Frame
    upt to 12 months from the beginning
    Secondary Outcome Measure Information:
    Title
    Health-Related Quality of Life
    Description
    Spanish version of the EQ-5D-5L questionnaire by the EuroQol Group
    Time Frame
    Baseline, 6 and 12 months from the beginning
    Other Pre-specified Outcome Measures:
    Title
    Chronic low-grade inflammation
    Description
    High sensibility c-reactive protein
    Time Frame
    Baseline, 6 and 12 months from the beginning

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age between 40-65 years Presence of any cardiovascular risk factors (Hypertension, Hypercholesterolemia, tobacco smoking, diabetes, obesity) Exclusion Criteria: Currently diagnosed with any vardiovascular disease Currently involved in any other clinical trial Cognitive impairment that prevents from providing an informed consent

    12. IPD Sharing Statement

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